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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vehicle, motorized 3-wheeled
510(k) Number K042763
Device Name MODIFICATION TO MEDLINE STRIDER MIDI 3
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact ANDREA HAFERKAMP
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact ANDREA HAFERKAMP
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/05/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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